A Phase I/II Study of Intrathecal Trastuzumab in Women with HER2-Positive Breast Cancer that Spread to the Spinal Fluid

Trastuzumab (Herceptin) is approved for treating breast cancers that produce high levels of a protein called HER2. It is typically given intravenously. However, when the cancer spreads to the brain or spinal cord, trastuzumab is unable to pass through the blood-brain barrier to kill cancer cells.

In this study, researching are determining the highest level of trastuzumab that can be delivered directly into the spinal fluid in women whose HER2-positive breast cancer spread to that area (what is called “leptomeningeal disease”).

barrier (BAYR-ee-er)

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

breast (brest)

Glandular organ located on the chest. The breast is made up of connective tissue, fat, and breast tissue that contains the glands that can make milk. Also called mammary gland.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

breast cancer (brest KAN-ser)

Cancer that forms in tissues of the breast, usually the ducts (tubes that carry milk to the nipple) and lobules (glands that make milk). It occurs in both men and women, although male breast cancer is rare.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

cancer (KAN-ser)

A term for diseases in which abnormal cells divide without control and can invade nearby tissues. Cancer cells can also spread to other parts of the body through the blood and lymph systems. There are several main types of cancer. Carcinoma is a cancer that begins in the skin or in tissues that line or cover internal organs. Sarcoma is a cancer that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue. Leukemia is a cancer that starts in blood-forming tissue such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the blood. Lymphoma and multiple myeloma are cancers that begin in the cells of the immune system. Central nervous system cancers are cancers that begin in the tissues of the brain and spinal cord. Also called malignancy.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

dose (dose)

The amount of medicine taken, or radiation given, at one time.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

fluid (FLOO-id)

A substance that flows smoothly and takes the shape of its container. Liquids and gases are fluids.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

intrathecal (IN-truh-THEE-kul)

Describes the fluid-filled space between the thin layers of tissue that cover the brain and spinal cord. Drugs can be injected into the fluid or a sample of the fluid can be removed for testing.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

leptomeningeal (LEP-toh-meh-NIN-jee-ul)

Having to do with the two innermost meninges (thin layers of tissue that cover and protect the brain and spinal cord).

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

protein (PROH-teen)

A molecule made up of amino acids that are needed for the body to function properly. Proteins are the basis of body structures such as skin and hair and of substances such as enzymes, cytokines, and antibodies.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

radiation (RAY-dee-AY-shun)

Energy released in the form of particle or electromagnetic waves. Common sources of radiation include radon gas, cosmic rays from outer space, medical x-rays, and energy given off by a radioisotope (unstable form of a chemical element that releases radiation as it breaks down and becomes more stable).

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

spinal cord (SPY-nul kord)

A column of nerve tissue that runs from the base of the skull down the back. It is surrounded by three protective membranes, and is enclosed within the vertebrae (back bones). The spinal cord and the brain make up the central nervous system, and spinal cord nerves carry most messages between the brain and the rest of the body.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

systemic (sis-TEH-mik)

Affecting the entire body.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

therapy (THAYR-uh-pee)

Treatment.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)

trastuzumab (tras-TOO-zoo-mab)

A drug used to treat breast cancer that is HER2-positive (expresses the human epidermal growth factor receptor 2). It is also used with other drugs to treat HER2-positive stomach cancer that has not already been treated and has spread to other parts of the body. It is being studied in the treatment of other types of cancer. Trastuzumab binds to HER2 on the surface of HER2-positive cancer cells, and may kill them. It is a type of monoclonal antibody. Also called Herceptin.

Source: The National Cancer Institute's Dictionary of Cancer Terms(http://www.cancer.gov/dictionary)